NCT04541550

Allogeneic Micronized Amniotic Membrane Product for the Treatment of Hidradenitis Suppurativa

An Open-label, Dose-escalation Study to Evaluate the Use of Allogeneic Micronized Amniotic Membrane Product for the Treatment of Hidradenitis Suppurativa

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: IntegoGen, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label, dose-escalation study enrolling 15 participants. There are 3 cohorts: 1. Cohort I: 5 subjects each receiving 1 injection of IGN-AMP001 (12.5mg AMP-001 in 3ml Saline) 2. Cohort II: 5 subjects each receiving 1 injection of IGN-AMP001 (25 mg AMP-001 in 3 ml Saline) 3. Cohort III: 5 subjects each receiving 1 injection of IGN-AMP001 (50 mg AMP-001 in 3 ml Saline).

Detailed description

Hidradenitis Suppurativa (HS) is a chronic inflammatory skin disease characterized by recurrent deep-seated boil-like abscesses and tracts under the skin. The most severe HS lesions are characterized by chronic non-healing sinuses, which form a wound-like environment as the abscesses heal; they produce significant skin scarring. Transcriptomic analysis of lesioned skin from HS patients suggests that it has similar pathology to other chronic wounds. IntegoGen's investigational product, IGN-AMP001, is manufactured from the amniotic membrane of the human placenta. The amnion membrane contains various cytokines and growth factors that promote wound healing. Local application of micronized dehydrated amnion membrane has been shown effective in treating chronic refractory non-healing dermal wounds of various etiologies in randomized clinical trials and case studies, which suggests it might be effective in treating HS wounds as well. Patients treated with IGN-AMP001 within IntegoGen associated clinics and other regenerative clinics have indicated positive responses. This study is designed to evaluate the safety, tolerability, and potential efficacy of IGN-AMP001 for HS.

Conditions

• Hidradenitis Suppurativa

Interventions

Type	Name	Description
DRUG	AMP-001 Low Dose	AMP-001, is manufactured from the amniotic membrane of the placenta and does not contain living cells.
DRUG	AMP-001 Medium Dose	AMP-001, is manufactured from the amniotic membrane of the placenta and does not contain living cells.
DRUG	AMP-001 High Dose	AMP-001, is manufactured from the amniotic membrane of the placenta and does not contain living cells.

Timeline

• Start date: 2021-04-01
• Primary completion: 2021-07-01
• Completion: 2021-07-01
• First posted: 2020-09-09
• Last updated: 2021-09-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study